ObesityNCT06103552
BLOOM Forward: Investigating Weight Loss Impact on TJAC Patients
A study testing Building Lifestyle Options for Orthopedic Mobility (BLOOM) in people with Obesity and Knee Osteoarthritis, run by Ottawa Hospital Research Institute.
Trial summary
The goal of this clinical trial is to prospectively assess the efficacy of the BLOOM program, a comprehensive weight loss dietary and lifestyle program, in a population of patients living with obesity and awaiting hip or knee surgery. The main questions it seeks to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Knee Osteoarthritis, Hip Osteoarthritis
- What is being tested?
- Building Lifestyle Options for Orthopedic Mobility (BLOOM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for the study, subjects must meet all the following criteria:
- Age ≥ 18 years old
- Body mass index (BMI) ≥ 35 kg/m2
- Have being identified as a potential orthopedic surgery candidate by the Total Joint Assessment Clinic (TJAC)
- Have a referral by their primary care practitioner
- Ready to participate actively in the program (i.e., readiness to change scale score ≥7)
- Acquisition of the required technology tools and skills to use the virtual platform (the BLOOM program will be conducted via virtual video conference)
- English comprehension at a level that allows for active participation in the program
Who cannot join
- Subjects who meet any of the following criteria are not eligible for the study:
- Active eating disorder
- Active substance use disorder
- Active smoking
- Currently or past enrollment in another weight loss program in the previous year prior to enrollment in the study
- Ongoing pregnancy or breastfeeding
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Building Lifestyle Options for Orthopedic Mobility: Preoperative Weight Loss and Impact on Health in People Living With Obesity Awaiting Orthopedic Procedure
The goal of this clinical trial is to prospectively assess the efficacy of the BLOOM program, a comprehensive weight loss dietary and lifestyle program, in a population of patients living with obesity and awaiting hip or knee surgery. The main questions it seeks to answer are:
- Can the BLOOM program support these patients to lose up to 10% of their initial body weight?
- Will patients continue to lose weight for the next six months after completing the program?
- Does the BLOOM program help patients to improve their overall quality of life?
Read more
Study participants will undergo the BLOOM program, a virtual pre-operative weight management program that spans 24 weeks and is carefully supervised by medical professionals. They will be recruited at the LEAF Clinic after being referred by their primary care physician.
During the BLOOM program, they will meet with a physician (initially, then once monthly) and a dietitian (initially, and then biweekly as part of virtual group coaching). They will have access to LEAF's online learning portal. These are normal elements of the BLOOM program.
Furthermore, as part of their participation in the research study, participants will be asked to complete the following questionnaires: the Mediterranean dietary score, the Oxford Hip and Knee Questionnaire and the EQ-D5-5L quality of life assessment. They will complete these initially, and then at completion of the program and 3 and 6 months post-program. We will also collect their height and weight at these intervals.
- Being tested
- Building Lifestyle Options for Orthopedic Mobility (BLOOM)
- Keywords
- Obesity, Body Mass Index, Weight Loss, Noncommunicable Diseases, Surveys and Questionnaires, Metabolic Disease, Arthroplasty, Osteoarthritis, Joint Diseases
- Medical subject headings
- Obesity, Osteoarthritis, Knee, Osteoarthritis, Hip, Weight Loss, Noncommunicable Diseases, Metabolic Diseases, Osteoarthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Lifestyle Options for Orthopedic Mobility (BLOOM)Behavioural
This intervention is a lifestyle program with includes dietary coaching from a dietitian and regular doctor appointments with a bariatric medicine specialist over the course of 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss Program Intervention | Experimental | All study participants will be assigned to the intervention arm of this trial where they will undergo the BLOOM lifestyle program for weight loss. This program is 24 weeks in duration and includes group nutrition coaching with a dietitian, regular physician appointments and access to online support materials. Participants may also choose to pursue weight loss medication or meal replacement therapy, although this is not specifically part of the BLOOM program being studied. Receives: Behavioral: Building Lifestyle Options for Orthopedic Mobility (BLOOM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
The difference (in lbs and %) in weight between the admission visit and the end of the BLOOM program
Measured: Weight will be compared from beginning of program to end of program, six months after program completion, and also monthly for months 1-5.
Secondary outcomes (7)
Weight - BMI 35-40
The difference (in lbs and %) in weight between the admission visit and the end of the BLOOM program for individuals with a BMI of 35-39.9
Measured: Six months
Weight - BMI 40+
The difference (in lbs and %) in weight between the admission visit and the end of the BLOOM program for individuals with a BMI over 40
Measured: Six months
Mediterranean Diet Score
The change in the Mediterranean Dietary Score between the initial visit and the end of the BLOOM program and 3 and 6 months after
Measured: At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)
Oxford Knee and Hip
The change in the Oxford Hip and Knee Questionnaires between the initial visit and the end of the BLOOM program and three and six months after.
Measured: At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)
EQ-5D-5L
The change in the EQ-5D-5L quality of life (QoL) score between the initial visit and the end of the BLOOM program and three and six months after.
Measured: At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)
Decision change
The proportion of patients that have a change of decision for joint arthropathy.
Measured: Twelve months
Weight change
The proportion of patients who continued to lose weight or maintained their weight 3 and 6 months after the end of the program
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label, single arm, cohort study.
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- LEAF Weight Loss Clinic, The Ottawa Hospital
- Responsible party
- Principal investigator, Judy Shiau, Ottawa Hospital Research Institute
- Investigators
- Judy Shiau, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103552
- Sponsor's protocol ID
- 20230569-01H
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share IPD with other researchers, nor are we seeking institutional ethical approval for such sharing.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Lifestyle Options for Orthopedic Mobility: Preoperative Weight Loss and Impact on Health in People Living With Obesity Awaiting Orthopedic Procedure
- ClinicalTrials.gov ID
- NCT06103552
- Acronym / sponsor ID
- 20230569-01H
- Keywords
- Obesity, Body Mass Index, Weight Loss, Noncommunicable Diseases, Surveys and Questionnaires, Metabolic Disease, Arthroplasty, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- LEAF Weight Loss Clinic, The Ottawa Hospital
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to prospectively assess the efficacy of the BLOOM program, a comprehensive weight loss dietary and lifestyle program, in a population of patients living with obesity and awaiting hip or knee surgery. The main questions it seeks to answer are:
- Can the BLOOM program support these patients to lose up to 10% of their initial body weight?
- Will patients continue to lose weight for the next six months after completing the program?
- Does the BLOOM program help patients to improve their overall quality of life?
Study participants will undergo the BLOOM program, a virtual pre-operative weight management program that spans 24 weeks and is carefully supervised by medical professionals. They will be recruited at the LEAF Clinic after being referred by their primary care physician.
During the BLOOM program, they will meet with a physician (initially, then once monthly) and a dietitian (initially, and then biweekly as part of virtual group coaching). They will have access to LEAF's online learning portal. These are normal elements of the BLOOM program.
Furthermore, as part of their participation in the research study, participants will be asked to complete the following questionnaires: the Mediterranean dietary score, the Oxford Hip and Knee Questionnaire and the EQ-D5-5L quality of life assessment. They will complete these initially, and then at completion of the program and 3 and 6 months post-program. We will also collect their height and weight at these intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label, single arm, cohort study.
| Arm | Type | Receives |
|---|---|---|
| Weight Loss Program Intervention | Experimental | Behavioral: Building Lifestyle Options for Orthopedic Mobility (BLOOM)All study participants will be assigned to the intervention arm of this trial where they will undergo the BLOOM lifestyle program for weight loss. This program is 24 weeks in duration and includes group nutrition coaching with a dietitian, regular physician appointments and access to online support materials. Participants may also choose to pursue weight loss medication or meal replacement therapy, although this is not specifically part of the BLOOM program being studied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- To be eligible for the study, subjects must meet all the following criteria:
Key exclusion criteria (6 listed)
- Subjects who meet any of the following criteria are not eligible for the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Building Lifestyle Options for Orthopedic Mobility (BLOOM)This intervention is a lifestyle program with includes dietary coaching from a dietitian and regular doctor appointments with a bariatric medicine specialist over the course of 24 weeks. | Behavioural | Weight Loss Program Intervention |
Primary outcome
Weight loss
Time frame: Weight will be compared from beginning of program to end of program, six months after program completion, and also monthly for months 1-5.
The difference (in lbs and %) in weight between the admission visit and the end of the BLOOM program
7 secondary outcomes
Weight - BMI 35-40
Time frame: Six months
Weight - BMI 40+
Time frame: Six months
Mediterranean Diet Score
Time frame: At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)
Oxford Knee and Hip
Time frame: At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)
EQ-5D-5L
Time frame: At program start, at program completion (approx 6 months, 3 and 6 months post-program completion (total time: twelve months)
Decision change
Time frame: Twelve months
Weight change
Time frame: Twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No. There is currently no plan to share IPD with other researchers, nor are we seeking institutional ethical approval for such sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy Shiau, MD principal investigator
The Ottawa Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Building Lifestyle Options for Orthopedic Mobility (BLOOM) in people with Obesity and Knee Osteoarthritis, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lesley Ananny, BA (613-701-1222, lananny@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: Weight will be compared from beginning of program to end of program, six months after program completion, and also monthly for months 1-5.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.